New Fecal Incontinence Device Cleared for Females

The Food and Drug Administration (FDA) has granted marketing of Pelvalon’s Eclipse System for the treatment of fecal incontinence in females aged 18–75 years old who have had ≥4 episodes in a two-week period.

The Eclipse System device contains an inflatable balloon that is inserted in the vagina. When inflated, the balloon exerts pressure through the vaginal wall onto the rectal area, which reduces the number of fecal incontinence episodes. The patient is able to inflate and deflate the device as needed at home following an initial fitting and inflation by a clinician.

Data for the Eclipse System was reviewed through the FDA’s de novo classification process. A clinical trial evaluated 61 women with fecal incontinence treated with the device. Almost 80% of women experienced a 50% reduction in the number of episodes after one month of using the device. Device-related adverse events were reported as mild or moderate, and no surgeries were required.